This pilot clinical trial studies cabozantinib in treating men with castration-resistant prostate cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

I. To assess the impact of cabozantinib on markers of bone turnover and microenvironment in men with non-metastatic castration-resistant prostate cancer and to compare the findings in men with metastatic castration-resistant prostate cancer.

SECONDARY OBJECTIVES:

I. To describe the associated changes in dynamic histomorphometry at baseline and after 6 weeks of cabozantinib therapy in men with non-metastatic castration-resistant prostate cancer.

II. To characterize, describe, and compare the effects of cabozantinib in men with non-metastatic and metastatic bone disease with respect to the following measurements at baseline and on therapy: markers of bone metabolism in blood including bone specific alkaline phosphatase, alkaline phosphatase, lactate dehydrogenase (LDH); changes in markers of apoptosis, proliferation, and angiogenesis in biopsy specimens from both bone and soft tissue during therapy with cabozantinib.

TERTIARY OBJECTIVES:

I. Radiographic disease responses and toxicities will be monitored for all patients.

After completion of study treatment, patients are followed up for 4 weeks.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

Key Inclusion Criteria

The subject has a proven histologic diagnosis of prostate adenocarcinoma, but may have undergone prior surgery and/or radiation

The subject must currently have castration resistant prostate cancer defined as 2 serial rising prostate-specific antigens (PSAs) with a castrate level of testosterone (< 50 ng/dL)

A subject with non-metastatic castration-resistant prostate cancer (CRPC) may not have received prior chemotherapy unless in the neoadjuvant or adjuvant setting > 24 months ago and may not have received prior zoledronic acid or denosumab

A subject with metastatic CRPC must have bone metastases accessible for biopsy by computed tomography (CT) guidance

The subject must be willing to undergo sequential biopsy of bone or bone metastases

Adequate organ and bone marrow function.

The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document

The subject has uncontrolled, significant intercurrent or recent illness

The subject is unable to swallow tablets

The subject has a corrected QT interval (QTcF) > 500 ms within 28 days before day 1 of cycle 1

The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation or to tetracycline

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703065